NCT02932137

Brief Summary

The objective of this clinical study is to evaluate the potential effect of anti-infection of low-does IL-2 in patients with SLE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

8 months

First QC Date

October 8, 2016

Last Update Submit

March 14, 2018

Conditions

Systemic Lupus Erythematosus

Keywords

SLE,IL-2

Outcome Measures

Primary Outcomes (1)

  • Immunological Responses

    The increased intracellular factors which could reflect the organic immunity

    week 0 and week 10

Secondary Outcomes (1)

  • Virus titers

    week 0 and week 10

Other Outcomes (1)

  • SLEDAI Score

    week 0 and week 10

Study Arms (2)

Interleukin-2

EXPERIMENTAL

Interleukin-2 to treat activated SLE.

Drug: Interleukin-2

Traditional therapy

NO INTERVENTION

Treat activated SLE with glucocorticoid or immunosuppressor.

Interventions

Interleukin-2DRUG

Patients receive low dose recombinant human Interleukin-2（HrIL-2）

Also known as: Recombinant Human Interleukin-2,125Ala, SL Pharm
Interleukin-2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet the American College of Rheumatology criteria for the diagnosis of SLE.
  • Background treatment failed to control flares or to permit prednisone tapering
  • With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria\>0.5g/day), neuropsychiatric SLE.
  • Positive for at least one of the following laboratory tests: ANA\>1:160, anti-dsDNA, immunoglobulin\>20g/L, decreased C3 or C4, leukopenia\<3×10\^9/L, thrombocytopenia\<100×10\^9/L;
  • SLE disease activity index(SLEDAI) ≥ 8.
  • Negative HIV test.
  • Negative for hepatitis B and C virus.
  • Written informed consent form.

You may not qualify if:

  • Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
  • Serious infection such as bacteremia, sepsis;
  • Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
  • High-dose steroid pulse therapy (\>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
  • History of administration of rituximab or other biologics;
  • Purified protein derivative (tuberculin) \>10mm
  • Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
  • Inability to comply with IL-2 treatment regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (2)

  • Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

    PMID: 33687069DERIVED

  • He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.

    PMID: 31537547DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • Zhanguo Li, MD and PhD

    Peking University Institute of Rheumatology and Immunology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and chief of department of rheumatology and immunology

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 13, 2016

Study Start

May 5, 2016

Primary Completion

December 16, 2016

Study Completion

August 30, 2017

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

CN(1)